Medical affairs Jobs in Lowell, MA

BioTalent is partnered with a fast-growing device manufacturer as they dive into the IVD market to find a strong Regulatory Affairs Manager to join their ranks. You will get to drive regulatory changes throughout new and existing product lines to align with both FDA and EU regulations while showcasing your leadership skills to upper management.

Key Responsibilities :

• Develop and implement regulatory strategies to facilitate timely approvals for new and existing products.
• Manage global product registrations, licensing, and regulatory compliance across key markets.
• Serve as the primary liaison with regulatory bodies, including the FDA, Notified Bodies, and international agencies.
• Oversee the preparation and submission of regulatory documentation to ensure compliance with global standards.
• Support regulatory compliance throughout the product lifecycle, including post-market surveillance activities.
• Lead efforts to transition products from IVDD to IVDR compliance.
• Collaborate with quality assurance teams to align regulatory and quality system requirements.
• Guide and support the expansion of the Regulatory Affairs function, including hiring, training, and mentoring team members.
• Manage external consultants, contractors, and regulatory support resources.
• Foster a culture of compliance, quality, and continuous improvement across the organization.

Qualifications & Experience :

Benefits for the Regulatory Affairs Manager